What are the responsibilities and job description for the Quality Engineer position at Brio Group?
Design Quality Engineer, Software
Location : San Diego, CA
The Opportunity
Are you ready to make an impact in the medical device space? Join a dynamic and innovative team revolutionizing the field of In Vitro Diagnostics (IVD). As a Design Quality Engineer, Software , you’ll play a critical role in implementing and maintaining software quality processes to ensure compliance and create cutting-edge solutions that enhance patient care.
About the Role
This position will focus on driving the Software Development Lifecycle (SDLC) and software risk management processes within a robust Quality Management System (QMS). You’ll work cross-functionally to ensure regulatory and industry standards are met, all while fostering a culture of quality excellence.
What You’ll Do :
- Lead the implementation of SDLC processes aligned with applicable regulations, standards, and industry guidance.
- Approve software documentation for premarket submissions, including risk management records, software architecture diagrams, and verification / validation reports.
- Facilitate hazard analyses and failure modes effects analyses (FMEA) for software design controls.
- Ensure agile software development practices align with regulatory requirements, maintaining Design History File (DHF) deliverables across layers (story, increment, release).
- Collaborate with project teams to resolve roadblocks, escalate quality issues, and ensure adherence to project plans.
- Monitor QMS processes, ensuring they achieve intended results and implementing corrective / preventative actions as needed.
- Deliver training on updated processes, promote compliance, and cultivate a quality-first culture.
What We’re Looking For :
We’re seeking an individual who thrives in fast-paced, collaborative environments and is passionate about delivering high-quality, impactful solutions.
Key Qualifications :
Why Join Us?
This is your chance to join a team at the forefront of innovation in the IVD space. Be part of a company committed to making a difference in healthcare through cutting-edge technology and uncompromising quality.